Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)

Low Back Pain Clinical Trial

— LESS  

Official title:

Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238536
• Other study ID #: 39023D
• Secondary ID: R01HS019222-01
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2010
• Last updated: November 15, 2017
• Start date: April 2011
• Est. completion date: September 2015

Study information

• Verified date: November 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.

Description:

Lumbar spinal stenosis is one of the most common causes of low back pain in the elderly and can lead to significant disability. The symptoms of spinal stenosis range from low back pain to neurogenic claudication with lower extremity pain, weakness and/or sensory changes related to activities. As spinal stenosis can affect the central canal as well as the lateral recesses and intervertebral foramen variably, symptoms can involve single or multiple myotomes and dermatomes. Since the causes of spinal stenosis are most frequently degenerative changes, the symptoms of spinal stenosis often, but not always, worsen over time. Despite the prevalence of spinal stenosis, treatment of spinal stenosis remains somewhat controversial. Common treatments include conservative measures such as non-steroidal anti-inflammatories (NSAIDS), activity modification and physical therapy as well as more invasive treatments such as epidural steroid injections and surgery. Although surgery has been demonstrated to provide some benefit to many individuals with spinal stenosis, ESI are being used with increasing frequency as a less invasive, potentially more cost effective and safer treatment for spinal stenosis. However, there is a lack of data to demonstrate the effectiveness and safety of epidural steroid injections for spinal stenosis, particularly in the older adults.

Because of the compelling need for effective therapy for patients suffering from spinal stenosis and because epidural steroid injections are rapidly becoming standard of care for treating these patients - even in the absence of compelling clinical evidence - we are conducting a randomized, controlled trial in order to test the hypothesis that lumbar epidural steroid injections improve functional status and pain associated with spinal stenosis. The main objective of the study is to conduct a blinded, randomized controlled trial (RCT) in elderly patients with spinal stenosis to test if the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than LA alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing, walking and/or spinal extension (buttock/leg>back pain).

2. Modified Roland-Morris score of at least 7.

3. Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.

4. Lower extremity symptoms consistent with neurogenic claudication.

5. Must be able to read English and complete the assessment instruments.

6. Age 50 or older.

Exclusion Criteria:

1. Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.

2. Clinical co-morbidities that could interfere with the collection of data concerning pain and function.

Known dx of fibromyalgia, chronic widespread pain, amputees, parkinsons, head injury, dementia, stroke, other neurologic conditions Collect date about cervical spinal stenosis, painful peripheral neuropathy, EMGs

3. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).

4. Spinal instability requiring surgical fusion.

5. Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.

6. Metastatic cancer.

7. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.

8. Possible pregnancy or other reason that precludes the use of fluoroscopy.

9. Concordant pain with internal rotation of the hip (or known hip joint pathology).

10. Active local or systemic infection.

11. Abnormal coagulation.

12. Allergy to local anesthetic, steroid or contrast.

13. Previous lumbar spine surgery.

14. Epidural steroid injection within previous 6 months.

Related Conditions & MeSH terms

• Back Pain
• Constriction, Pathologic
• Low Back Pain
• Spinal Stenosis

Intervention

Procedure:
• Epidural steroid with local anesthetic injection
Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
• Epidural local anesthetic injection
Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Drug:
• Epidural steroid injection
Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
• Epidural local anesthetic injection
Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dallas VA Medical Center	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Oregon Health and Science University	Portland	Oregon
United States	Kaiser Permanente Northern California	Redwood City	California
United States	Virginia Spine Research Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Kaiser Permanente Northern California	Roseville	California
United States	Harborview Medical Center, University of Washington	Seattle	Washington

Sponsors (13)

Lead Sponsor	Collaborator
University of Washington	Dallas VA Medical Center, Harvard Pilgrim Health Care, Harvard Vanguard Medical Associates, Henry Ford Hospital, Kaiser Permanente, Massachusetts General Hospital, Mayo Clinic, Oregon Health and Science University, Stanford University, University of California, San Francisco, University of Colorado, Denver, Virginia Spine Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

Friedly JL, Bresnahan BW, Comstock B, Turner JA, Deyo RA, Sullivan SD, Heagerty P, Bauer Z, Nedeljkovic SS, Avins AL, Nerenz D, Jarvik JG. Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord. 2012 Mar 29;13:48. doi: 10.1186/1471-2474-13-48. — View Citation

Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Sullivan SD, Bauer Z, Bresnahan BW, Avins AL, Nedeljkovic SS, Nerenz DR, Standaert C, Kessler L, Akuthota V, Annaswamy T, Chen A, Diehn F, Firtch W, Gerges FJ, Gilligan C, Goldberg H, Kennedy DJ, M — View Citation

Suri P, Pashova H, Heagerty PJ, Jarvik JG, Turner JA, Comstock BA, Bauer Z, Annaswamy TM, Nedeljkovic SS, Wasan AD, Friedly JL. Short-term improvements in disability mediate patient satisfaction after epidural corticosteroid injections for symptomatic lum — View Citation

Turner JA, Comstock BA, Standaert CJ, Heagerty PJ, Jarvik JG, Deyo RA, Wasan AD, Nedeljkovic SS, Friedly JL. Can patient characteristics predict benefit from epidural corticosteroid injections for lumbar spinal stenosis symptoms? Spine J. 2015 Nov 1;15(11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris	The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.	6 weeks
Secondary	Pain Numeric Rating Scale	Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week.	6 weeks
Secondary	Roland Morris Disability Questionnaire (RDQ)	The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.	12 months
Secondary	Leg Pain NRS	Leg Pain NRS 0-10 scale	12 months